Chronic Obstructive Pulmonary Disease Clinical Trial
— LAS-MD-38Official title:
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose
The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.
Status | Completed |
Enrollment | 544 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2008; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 = 30% and < 80% predicted - Current or former cigarette smokers Exclusion Criteria: - Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit - Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1 - Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness - History or presence of asthma verified from medical records - Chronic use of oxygen therapy greater than or equal to 15 hours per day - Patient with uncontrolled infection due to HIV and/or active hepatitis - Patients with a history of hypersensitivity reaction to inhaled anticholinergics - Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Forest Investigative Site 1177 | Vancouver | British Columbia |
Canada | Forest Investigative Site 0969 | Windsor | Ontario |
United States | Forest Investigative Site 1480 | Abingdon | Virginia |
United States | Forest Investigative Site 1486 | Albuquerque | New Mexico |
United States | Forest Investigative Site 1389 | Amarillo | Texas |
United States | Forest Investigative Site 1479 | Anderson | Indiana |
United States | Forest Investigative Site 1440 | Arlington | Texas |
United States | Forest Investigative Site 1386 | Atlanta | Georgia |
United States | Forest Investigative Site 1494 | Austin | Texas |
United States | Forest Investigative Site 1412 | Baltimore | Maryland |
United States | Forest Investigative Site 1354 | Bellevue | Nebraska |
United States | Forest Investigative Site 1367 | Bellevue | Nebraska |
United States | Forest Investigative Site 1419 | Birmingham | Alabama |
United States | Forest Investigative Site 1493 | Birmingham | Alabama |
United States | Forest Investigative Site 2033 | Bowling Green | Kentucky |
United States | Forest Investigative Site 1442 | Brockton | Massachusetts |
United States | Forest Investigative Site 1411 | Calhoun | Georgia |
United States | Forest Investigative Site 1392 | Charlotte | North Carolina |
United States | Forest Investigative Site 1405 | Chelsea | Michigan |
United States | Forest Investigative Site 1136 | Cincinnati | Ohio |
United States | Forest Investigative Site 1371 | Cincinnati | Ohio |
United States | Forest Investigative Site 1364 | Clearwater | Florida |
United States | Forest Investigative Site 0679 | Coeur d' Alene | Idaho |
United States | Forest Investigative Site 1377 | Collegeville | Pennsylvania |
United States | Forest Investigative Site 1144 | Columbia | South Carolina |
United States | Forest Investigative Site 1361 | Columbus | Ohio |
United States | Forest Investigative Site 1433 | Columbus | Ohio |
United States | Forest Investigative Site 1517 | Easley | South Carolina |
United States | Forest Investigative Site 1516 | Edgewater | Florida |
United States | Forest Investigative Site 1128 | Edina | Minnesota |
United States | Forest Investigative Site 1385 | Elk Grove Village | Illinois |
United States | Forest Investigative Site 1423 | Erie | Pennsylvania |
United States | Forest Investigative Site 2022 | Evansville | Indiana |
United States | Forest Investigative Site 1421 | Fall River | Massachusetts |
United States | Forest Investigative Site 1526 | Fayetteville | Tennessee |
United States | Forest Investigative Site 1428 | Feasterville | Pennsylvania |
United States | Forest Investigative Site 1476 | Fremont | Nebraska |
United States | Forest Investigative Site 1527 | Fridley | Minnesota |
United States | Forest Investigative Site 2065 | Fullerton | California |
United States | Forest Investigative Site 1380 | Golden | Colorado |
United States | Forest Investigative Site 1506 | Grenville | South Carolina |
United States | Forest Investigative Site 1090 | Hazard | Kentucky |
United States | Forest Investigative Site 1359 | Henderson | Nevada |
United States | Forest Investigative Site 1366 | High Point | North Carolina |
United States | Forest Investigative Site 1403 | Hollywood | Florida |
United States | Forest Investigative Site 1485 | Homestead | Florida |
United States | Forest Investigative Site 1375 | Houston | Texas |
United States | Forest Investigative Site 1381 | Houston | Texas |
United States | Forest Investigative Site 1401 | Houston | Texas |
United States | Forest Investigative Site 1444 | Houston | Texas |
United States | Forest Investigative Site 1357 | Hurst | Texas |
United States | Forest Investigative Site 1441 | Indianapolis | Indiana |
United States | Forest Investigative Site 1406 | Iowa City | Iowa |
United States | Forest Investigative Site 1445 | Johnston | Rhode Island |
United States | Forest Investigative Site 1356 | Knoxville | Tennessee |
United States | Forest Investigative Site 1417 | Knoxville | Tennessee |
United States | Forest Investigative Site 1489 | Larchmont | New York |
United States | Forest Investigative Site 1355 | Las Vegas | Nevada |
United States | Forest Investigative Site 1528 | Lawrenceville | Georgia |
United States | Forest Investigative Site 1477 | Lincoln | Rhode Island |
United States | Forest Investigative Site 0889 | Livonia | Michigan |
United States | Forest Investigative Site 1402 | Lynchburg | Virginia |
United States | Forest Investigative Site 2018 | Medford | Oregon |
United States | Forest Investigative Site 2043 | Medford | Oregon |
United States | Forest Investigative Site 1352 | Miami | Florida |
United States | Forest Investigative Site 1124 | Minneapolis | Minnesota |
United States | Forest Investigative Site 1400 | Missoula | Montana |
United States | Forest Investigative Site 1413 | Muscle Shoals | Alabama |
United States | Forest Investigative Site 1391 | Naples | Florida |
United States | Forest Investigative Site 1451 | National City | California |
United States | Forest Investigative Site 1430 | New Orleans | Louisiana |
United States | Forest Investigative Site 1446 | New Orleans | Louisiana |
United States | Forest Investigative Site 1425 | New York | New York |
United States | Forest Investigative Site 1404 | Norfolk | Virginia |
United States | Forest Investigative Site 1029 | North Dartmouth | Massachusetts |
United States | Forest Investigative Site 1518 | North East | Maryland |
United States | Forest Investigative Site 1373 | North Syracuse | New York |
United States | Forest Investigative Site 1409 | O'Fallon | Illinois |
United States | Forest Investigative Site 1362 | Oklahoma City | Oklahoma |
United States | Forest Investigative Site 1363 | Omaha | Nebraska |
United States | Forest Investigative Site 1390 | Omaha | Nebraska |
United States | Forest Investigative Site 1422 | Omaha | Nebraska |
United States | Forest Investigative Site 1388 | Paramount | California |
United States | Forest Investigative Site 1353 | Pell City | Alabama |
United States | Forest Investigative Site 1443 | Philadelphia | Pennsylvania |
United States | Forest Investigative Site 1379 | Phoenix | Arizona |
United States | Forest Investigative Site 1510 | Pittsburgh | Pennsylvania |
United States | Forest Investigative Site 1426 | Plano | Texas |
United States | Forest Investigative Site 1376 | Port Orange | Florida |
United States | Forest Investigative Site 1447 | Pueblo | Colorado |
United States | Forest Investigative Site 1358 | Richmond | Virginia |
United States | Forest Investigative Site 1118 | Rochester | Minnesota |
United States | Forest Investigative Site 1424 | Rolling Hill Estates | California |
United States | Forest Investigative Site 1427 | Sacramento | California |
United States | Forest Investigative Site 1418 | San Diego | California |
United States | Forest Investigative Site 2009 | San Diego | California |
United States | Forest Investigative Site 1149 | South Bend | Indiana |
United States | Forest Investigative Site 1372 | South Miami | Florida |
United States | Forest Investigative Site 1399 | St. Louis | Missouri |
United States | Forest Investigative Site 1360 | Sunset | Louisiana |
United States | Forest Investigative Site 0988 | Tacoma | Washington |
United States | Forest Investigative Site 1449 | Tipton | Pennsylvania |
United States | Forest Investigative Site 1530 | Toledo | Ohio |
United States | Forest Investigative Site 1410 | Tomball | Texas |
United States | Forest Investigative Site 1080 | Topeka | Kansas |
United States | Forest Investigative Site 1374 | Torrance | California |
United States | Forest Investigative Site 1407 | Trinity | Florida |
United States | Forest Investigative Site 1487 | Troy | Michigan |
United States | Forest Investigative Site 1450 | Union | South Carolina |
United States | Forest Investigative Site 1331 | Vista | California |
United States | Forest Investigative Site 1185 | Winter Park | Florida |
United States | Forest Investigative Site 1393 | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories | Almirall, S.A. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF) | Change from baseline (Week 0) to Week 12 | No |
Primary | Part B: Morning Predose (Trough) FEV1 | Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF) | Change from baseline (Week 0) to 52 Weeks | No |
Secondary | Part A: Peak Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF) | Change from baseline (Week 0) to Week 12 | No |
Secondary | Part B: Peak FEV1 | Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF) | Change from baseline (Week 0) to 52 Weeks | No |
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